Continuous Outcomes Research Articles

Tension-Type Headache Management: A Systematic Review and Network Meta-analysis of Complementary and Alternative Medicine.

Tension-type headache (TTH) is common but challenging to manage due to limited effectiveness of conventional treatments. This study examines six complementary and alternative medicine (CAM) interventions through network meta-analysis to identify effective TTH management strategies. We searched PubMed, Embase, Web of Science, Cochrane Library, OVID, CNKI, Wanfang, VIP, and CBM databases for randomized controlled trials on CAM for TTH treatment. Headache frequency and intensity were the primary outcomes. Methodological quality was evaluated on the basis of the Cochrane risk of bias tool. We used R software to conduct this Bayesian network meta-analysis. We used mean difference (MD) with 95% credible intervals (CI) to calculate the continuous outcomes and analyzed the percentages of the surface under the cumulative ranking (SUCRA) curve. In total, 32 randomized controlled trials (RCTs) with 2405 participants were analyzed. For reducing headache intensity, the network meta-analysis shows that acupuncture therapy combined with traditional Chinese medicine (AT_TCM), manual therapy (MT), psychological treatment (PT), and traditional Chinese medicine combined with acupuncture and manual therapy (TCM_AT_MT) are superior to Western medicine (WM). In the SUCRA curve, TCM_AT_MT is the best for reducing headache frequency (HF). This review, assessed as low-quality evidence by GRADE, cautiously suggests potential benefits of PT over other CAM interventions for TTH and indicates TCM_AT_MT might better reduce HF. It proposes that combining CAM interventions could enhance outcomes. Due to the preliminary nature of these findings, further high-quality RCTs are essential to confirm these suggestions and provide clearer clinical guidance. CRD42021252073.

Efficacy and safety of radiofrequency ablation and laparoscopic adrenalectomy for primary aldosteronism: a meta‑analysis.

To compare the efficacy (including blood pressure, medication reduction, serum potassium, and clinical success) and safety parameters (including operative time, length of hospital stay, blood loss, hypertension crisis rate, and complication rate) of radiofrequency ablation (RFA) and laparoscopic adrenalectomy (LA) in the treatment of primary aldosteronism (PA). Literature search was performed on PubMed, EMBASE, The Cochrane Library (Issue 8, 2023), Web of Science, China National Knowledge Infrastructure, and Wanfang from inception to August 2023. Study selection, data extraction, and risk of bias assessment were performed by two independent reviewers. Quality assessment was conducted using the Newcastle-Ottawa scale. The Stata 12.0 software was used for statistical analyses. Pooled odds ratios (OR) with corresponding 95% confidence interval (CI) were calculated for categorical outcomes, while mean difference (MD) with corresponding 95% CI were calculated for continuous outcomes. A total of 5 studies involving 204 patients (LA, n = 127; and RAF, n = 77) were included. LA had better diastolic blood pressure control than RFA (WMD = 5.19; 95% CI 0.96-9.43); however, the RFA demonstrated better shorter operative time (WMD = - 57.99; 95% CI - 116.54 to 0.57), and shorter length of hospital stay (OR - 1.6; 95% CI - 2.37 to - 0.83) compared to LA. All remaining parameters were comparable between the interventions. While grossly comparable in efficacy as treatment options for PA, RFA may allow for shorter operative time and hospital stay, less intraoperative blood loss, and lower hospitalization costs. However, LA has better diastolic blood pressure control. Even so, we still need larger prospective studies, specifically with comparative hypertension response (short and long term) and number of post-procedural antihypertensive medication requirement.

The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia.

A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy, which has adverse maternal and newborn outcomes. Couple-focused interventions are effective in reducing and/or controlling violence between women and their intimate partners. However, interventions addressing intimate partners of the victims are not well studied, particularly in the Ethiopian setting. This study aims to assess the effect of couple-based violence prevention education on intimate partner violence during pregnancy. We will use a cluster randomized controlled trial to evaluate the effectiveness of couple-based violence prevention education compared to routine care in reducing intimate partner violence during pregnancy. Sixteen kebeles will be randomly assigned to 8 interventions and 8 control groups. In the trial, 432 couples whose wife is pregnant will participate. Health extension workers (HEWs) will provide health education. Data will be collected at baseline and endline. All the collected data will be analyzed using Stata version 16.0 or SPSS version 25.0. We will use the McNemar test to assess the differences in outcomes of interest in both intervention and control groups before and after the intervention for categorical data. A paired t-test will be used to compare continuous outcome of interest in the intervention and the control groups after and before the intervention. The GEE (Generalized Estimating Equation), will be used to test the independent effect of the intervention on the outcome of the interest. Data analysis will be performed with an intention-to-treat analysis approach. During the analysis, the effect size, confidence interval, and p-value will be calculated. All tests will be two-sided, and statistical significance will be declared at p < 0.05. We expect that the study will generate findings that can illuminate violence prevention strategies and practices in Ethiopia. It has been registered on ClinicalTrials.gov as NCT05856214 on May 4, 2023.

Uterine Artery Embolization Versus Hysterectomy in Postpartum Hemorrhage: A Systematic Review With Meta-Analysis.

The objective of this study is to perform a meta-analysis comparing the effectiveness of uterine artery embolization (UAE) versus peripartum hysterectomy for acute refractory postpartum hemorrhage (PPH) control. We systematically searched 6 medical databases for studies comparing UAE and hysterectomy in PPH. Outcomes examined were mortality, hospitalization duration (HD) in days, and red blood cells (RBC) units utilization. Statistical analysis used RevMan 5.1.7 and random-effects models. Odds ratios (OR) and mean differences (MDs) with 95% confidence intervals (CIs) were used for dichotomous and continuous outcomes, respectively. We included 833 patients from 4 cohort studies, with 583 (70%) undergoing UAE. The UAE population required fewer RBC units (MD: -7.39; 95% CI: -14.73 to -0.04; p=0.05) and had shorter HD (MD: -3.22; 95% CI: -5.42 to -1.02; p=0.004). Lower mortality rates were noted for UAE in the pooled analysis, but no statistical significance. Uterine artery embolization demonstrated lower procedural complications (16.45% vs. 28.8%), in which UAE had less ureter and bladder lesions (OR: 0.05; 95% CI: 0.01-0.38; p=0.004 and OR: 0.02; 95% CI: 0.00-0.15; p<0.001, respectively). Only 35 (6%) required conversion to hysterectomy, while 27 (4.6%) underwent re-embolization with 100% bleeding control. Uterine artery embolization did not hinder fertility, with normal menstruation restored in 19 patients with postoligomenorrhea. Uterine artery embolization for the control of PPH is associated with lower use of RBC units and HD, but similar rates of mortality are noted when compared to hysterectomy. These results associated with uterine preservation could support its importance for refractory PPH management. Uterine Artery Embolization is associated with a shorter hospitalization duration and reduced use of red blood cell units when compared with hysterectomy in refractory postpartum hemorrhage. Although demonstrating similar mortality rates, these findings, together with fertility preservation, support the method incorporation as a valuable option in obstetric services.

PCI Vs. CABG: Battle For Better Outcomes in Pakistani Triple Vessel Disease Patients

Background: Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, with Triple Vessel Disease (TVD) representing a severe form that poses significant treatment challenges. In Pakistan, the burden of CVDs is high, exacerbated by genetic and lifestyle factors. Objective: To evaluate and compare the clinical outcomes of Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Grafting (CABG) in patients diagnosed with Triple Vessel Disease (TVD) in a Pakistani cohort. Methods: This prospective cohort study was conducted at Lady Reading Hospital, Peshawar, from January 1, 2020, to December 31, 2021. A total of 400 patients diagnosed with TVD based on angiographic findings were enrolled. Inclusion criteria included age above 18 years, clinical diagnosis of stable angina or non-ST elevation myocardial infarction, and consent to participate. Exclusion criteria were previous revascularization procedures, concomitant valvular or congenital heart disease, and life expectancy less than a year due to non-cardiac conditions. Patients were assigned to either PCI or CABG based on clinical decisions by their managing cardiologists, considering anatomical considerations, comorbid conditions, and patient preferences. Baseline demographic and clinical data, including age, gender, smoking status, presence of diabetes, hypertension, and previous myocardial infarction (MI), were collected through patient interviews and medical record reviews. Clinical outcomes were monitored for 12 months post-procedure. Primary outcome measures included mortality, myocardial infarction, repeat revascularization, and stroke within 12 months. Secondary outcomes were hospital readmission rates and quality of life scores, measured using a standardized 10-point scale. Statistical analyses were performed using SPSS version 25, with continuous variables expressed as means and standard deviations and categorical variables as percentages. The chi-square test or Fisher’s exact test was used for categorical outcomes, and the student’s t-test or Mann-Whitney U test for continuous outcomes, with a p-value of less than 0.05 considered statistically significant. Results: The mean age of the participants was 62.5 ± 7.8 years, with 62 ± 8 years in the PCI group and 63 ± 7 years in the CABG group (p=0.45). Gender distribution was similar, with 255 males and 145 females overall (p=0.55). Smoking status, diabetes, hypertension, and previous MI were comparably distributed between the groups. Mortality was 5% in the PCI group and 3% in the CABG group (p=0.31). Myocardial infarction occurred in 10% of PCI patients compared to 5% of CABG patients (p=0.05). Repeat revascularization was required in 15% of the PCI group versus 7% of the CABG group (p=0.01). Stroke incidence was 2% in the PCI group and 1% in the CABG group (p=0.45). Hospital readmission rates were 20% for PCI and 15% for CABG (p=0.10). Quality of life scores were higher in the CABG group (8.0 ± 1.1) compared to the PCI group (7.5 ± 1.2) (p=0.04). Conclusion: CABG may offer superior outcomes compared to PCI in managing TVD among Pakistani patients, particularly in reducing myocardial infarction rates and repeat revascularization. Despite the invasive nature of CABG, its long-term benefits suggest it should be considered preferentially for patients with complex coronary anatomies. Clinical decisions should, however, be tailored to individual patient factors and preferences.

Combining endpoint and change data did not affect the summary standardised mean difference in pairwise and network meta-analyses: An empirical study in depression.

When studies use different scales to measure continuous outcomes, standardised mean differences (SMD) are required to meta-analyse the data. However, outcomes are often reported as endpoint or change from baseline scores. Combining corresponding SMDs can be problematic and available guidance advises against this practice. We aimed to examine the impact of combining the two types of SMD in meta-analyses of depression severity. We used individual participant data on pharmacological interventions (89 studies, 27,409 participants) and internet-delivered cognitive behavioural therapy (iCBT; 61 studies, 13,687 participants) for depression to compare endpoint and change from baseline SMDs at the study level. Next, we performed pairwise (PWMA) and network meta-analyses (NMA) using endpoint SMDs, change from baseline SMDs, or a mixture of the two. Study-specific SMDs calculated from endpoint and change from baseline data were largely similar, although for iCBT interventions 25% of the studies at 3 months were associated with important differences between study-specific SMDs (median 0.01, IQR -0.10, 0.13) especially in smaller trials with baseline imbalances. However, when pooled, the differences between endpoint and change SMDs were negligible. Pooling only the more favourable of the two SMDs did not materially affect meta-analyses, resulting in differences of pooled SMDs up to 0.05 and 0.13 in the pharmacological and iCBT datasets, respectively. Our findings have implications for meta-analyses in depression, where we showed that the choice between endpoint and change scores for estimating SMDs had immaterial impact on summary meta-analytic estimates. Future studies should replicate and extend our analyses to fields other than depression.

Efficacy and Safety of Monoclonal Antibodies for the Treatment of Eosinophilic Esophagitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Monoclonal antibodies (MAbs) have clinical benefits for treating several atopic diseases. However, consensus on its use for eosinophilic esophagitis (EoE) is lacking. The present meta-analysis aimed to compare the efficacy and safety of MAbs versus placebo for treating EoE. We searched PubMed, Embase, and Cochrane Library for randomized controlled trials (RCTs). The primary outcomes were changes in peak esophageal eosinophils count/high power field (HPF) and mean esophageal eosinophils count/HPF. The secondary outcomes were changes in the EoE-Histology Scoring System (EoE-HSS), Endoscopic Reference Score (EREFS), dysphagia score, and adverse events (AEs). We compared binary outcomes using risk ratio (RR) and continuous outcomes using mean difference (MD) or standardized mean difference (SMD), with 95% confidence interval (CI). Considering the diversity of mechanistic properties of MAbs, a pre-specified subgroup analysis by MAb mechanism of action was performed for all outcomes, provided that at least two studies were in each subgroup. Heterogeneity was assessed using Cochran's Q test and I2 statistics. 6 RCTs were included (533 patients). Compared to placebo, MAbs led to a significant reduction in peak esophageal eosinophils count/HPF (MD -0.78; CI 95% -0.87, -0.6801) and mean esophageal eosinophils count/HPF (SMD-0.79; CI 95% -1.5, -0.08). Moreover, MAbs significantly reduced EoE-HSS scores (grade score: SMD-9.31; 95% CI -13.95, -4.6701; stage score: SMD -10.18; 95% CI -15.06, -5.31), EREFS (SMD-5.95; CI 95% -9.19, -2.71) and dysphagia score (SMD -1.79; CI 95% -3.36, -0.23) without increasing AEs compared to placebo. Among those MAbs whose mechanism of action includes the blockage of the receptor for IL-13 (Dupilumab, QAX576, and RPC4046), the scores of EoE-HSS grade, EoE-HSS stage, EREFS, and dysphagia were significantly reduced, and they presented a similar risk of overall and serious AEs compared to placebo. MAbs seem effective and safe in reducing esophageal eosinophil infiltrate, EoE-HSS score, EREFS score, and dysphagia symptoms in patients with EoE. However, further evidence is needed to establish its place in EoE management.

Caffeine intake enhances bowel recovery after colorectal surgery: a meta-analysis of randomized and non-randomized studies.

Postoperative ileus (POI) after colorectal surgery is a major problem thataffects both patient recovery and hospital costs highlighting the importance of preventive strategies. Therefore, we aimed to perform a systematic analysis of the effects of postoperative caffeine consumption on bowel recovery and surgical morbidity after colorectal surgery. A comprehensive literature search was conducted through September 2023 for randomized and non-randomized trials comparing the effect of caffeinated versus non-caffeinated drinks on POI by evaluating bowel movement resumption, time to first flatus and solid food intake, and length of hospital stay (LOS). Secondary outcome analysis included postoperative morbidity in both groups. After data extraction and inclusion in a meta-analysis, odds ratios (ORs) for dichotomous variables and standardized mean differences (SMDs) for continuous outcomes with 95% confidence intervals (CIs) were calculated. Subgroup analyses were performed in cases of substantial heterogeneity. Six randomized and two non-randomized trials with a total of 610 patients were included in the meta-analysis. Caffeine intake significantly reduced time to first bowel movement [SMD -0.39, (95% CI -0.66 to -0.12), p = 0.005] and time to first solid food intake [SMD -0.41, (95% CI -0.79 to -0.04), p = 0.03] in elective laparoscopic colorectal surgery, while time to first flatus, LOS, and the secondary outcomes did not differ significantly. Postoperative caffeine consumption may be a reasonable strategy to prevent POI after elective colorectal surgery. However, larger randomized controlled trials (RCTs) with homogeneous study protocols, especially regarding the dosage form of caffeine and coffee, are needed.

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients.

The risk of cytomegalovirus (CMV) infection in solid organ transplant recipients has resulted in the frequent use of prophylaxis to prevent the clinical syndrome associated with CMV infection. This is an update of a review first published in 2005 and updated in 2008 and 2013. To determine the benefits and harms of antiviral medications to prevent CMV disease and all-cause death in solid organ transplant recipients. We contacted the information specialist and searched the Cochrane Kidney and Transplant Register of Studies up to 5 February 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. We included randomised controlled trials (RCTs) and quasi-RCTs comparing antiviral medications with placebo or no treatment, comparing different antiviral medications or different regimens of the same antiviral medications for CMV prophylaxis in recipients of any solid organ transplant. Studies examining pre-emptive therapy for CMV infection are studied in a separate review and were excluded from this review. Two authors independently assessed study eligibility, risk of bias and extracted data. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. This 2024 update found four new studies, bringing the total number of included studies to 41 (5054 participants). The risk of bias was high or unclear across most studies, with a low risk of bias for sequence generation (12), allocation concealment (12), blinding (11) and selective outcome reporting (9) in fewer studies. There is high-certainty evidence that prophylaxis with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment is more effective in preventing CMV disease (19 studies: RR 0.42, 95% CI 0.34 to 0.52), all-cause death (17 studies: RR 0.63, 95% CI 0.43 to 0.92), and CMV infection (17 studies: RR 0.61, 95% CI 0.48 to 0.77). There is moderate-certainty evidence that prophylaxis probably reduces death from CMV disease (7 studies: RR 0.26, 95% CI 0.08 to 0.78). Prophylaxis reduces the risk of herpes simplex and herpes zoster disease, bacterial and protozoal infections but probably makes little to no difference to fungal infection, acute rejection or graft loss. No apparent differences in adverse events with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment were found. There is high certainty evidence that ganciclovir, when compared with aciclovir, is more effective in preventing CMV disease (7 studies: RR 0.37, 95% CI 0.23 to 0.60). There may be little to no difference in any outcome between valganciclovir and IV ganciclovir compared with oral ganciclovir (low certainty evidence). The efficacy and adverse effects of valganciclovir or ganciclovir were probably no different to valaciclovir in three studies (moderate certainty evidence). There is moderate certainty evidence that extended duration prophylaxis probably reduces the risk of CMV disease compared with three months of therapy (2 studies: RR 0.20, 95% CI 0.12 to 0.35), with probably little to no difference in rates of adverse events. Low certainty evidence suggests that 450 mg/day valganciclovir compared with 900 mg/day valganciclovir results in little to no difference in all-cause death, CMV infection, acute rejection, and graft loss (no information on adverse events). Maribavir may increase CMV infection compared with ganciclovir (1 study: RR 1.34, 95% CI: 1.10 to 1.65; moderate certainty evidence); however, little to no difference between the two treatments were found for CMV disease, all-cause death, acute rejection, and adverse events at six months (low certainty evidence). Prophylaxis with antiviral medications reduces CMV disease and CMV-associated death, compared with placebo or no treatment, in solid organ transplant recipients. These data support the continued routine use of antiviral prophylaxis in CMV-positive recipients and CMV-negative recipients of CMV-positive organ transplants.

Systematic review and meta-analysis of studies comparing cyst wall preservation against cyst wall resection during arthroscopic popliteal cyst decompression.

The optimal arthroscopic management for popliteal cyst decompression remains uncertain, with ongoing debate between preserving the cyst wall or completely removing it. The purpose of this study is to compare the outcomes and complications of arthroscopic popliteal cyst decompression with cyst wall preservation and cyst wall resection. A systematic review adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines was conducted. It encompassed studies that focused on arthroscopic popliteal cyst decompression, considering both cyst wall preservation and cyst wall resection. The quality assessment of the included studies was carried out using the Methodology Index for Non-Randomized Research criteria. Following this, meta-analyses were conducted, employing odds ratios (ORs) for dichotomous outcomes and calculating mean differences (MDs) for continuous outcomes. Four articles included a collective of 214 knees. Each of these studies presented level 3 evidence. The comparison between the cyst wall preservation group and the cyst wall resection group revealed similar clinical outcomes based on the Rauschning and Lindgren grade (grade 0 [OR = 0.66, 95% CI: 0.37-1.19, p = 0.17]; grade I [OR = 1.33, 95% CI: 0.66-2.67, p = 0.43]; grade II [OR = 1.39, 95% CI: 0.46-4.14, p = 0.56]; grade III [OR = 3.46, 95% CI: 0.13-89.95, p = 0.46]) and Lysholm score (MD = 0.83, 95% CI: -0.65-2.32, p = 0.27). However, MRI results indicated a significant improvement in the cyst wall resection group (cyst disappearance [OR = 0.50, 95% CI: 0.28-0.90, p = 0.02]; cyst shrinkage or decrease in size [OR = 1.41, 95% CI: 0.78-2.55, p = 0.26]; cyst persistence or recurrence [OR = 7.63, 95% CI: 1.29-45.08, p = 0.02]). Nevertheless, the operative time for cyst resection was significantly longer compared to cyst preservation (MD = -14.90, 95% CI: -21.96 - -7.84, p < 0.0001), and the cyst wall resection group experienced significantly higher complications than the cyst wall preservation group (OR = 0.24, 95% CI: 0.06 to 1.02, p = 0.05). During arthroscopic popliteal cyst decompression, cyst wall resection led to longer operative times and higher complication rates but lower recurrence rates and better MRI outcomes. The functional outcomes after surgery were found to be similar.

Risk assessment for aggressive behaviour in schizophrenia.

Aggressive or violent behaviour is often associated with people with schizophrenia in common perceptions of the disease. Risk assessment methods have been used to identify and evaluate the behaviour of those individuals who are at the greatest risk of perpetrating aggression or violence or characterise the likelihood to commit acts. Although many different interventions have been developed to decrease aggressive or violent incidences in inpatient care, staff working in inpatient settings seek easy-to-use methods to decrease patient aggressive events. However, many of these are time-consuming, and they require intensive training for staff and patient monitoring. It has also been recognised in clinical practice that if staff monitor patients' behaviour in a structured manner, the monitoring itself may result in a reduction of aggressive/violent behaviour and incidents in psychiatric settings. To assess the effects of structured aggression or violence risk assessment methods for people with schizophrenia or schizophrenia-like illnesses. We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PubMed, ISRCTN registry, ClinicalTrials.gov, and WHO ICTRP, on 10 February 2021. We also inspected references of all identified studies. We included all randomised controlled trials (RCTs) comparing structured risk assessment methods added to standard professional care with standard professional care for the evaluation of aggressive or violent behaviour among people with schizophrenia. At least two review authors independently inspected citations, selected studies, extracted data, and appraised study quality. For binary outcomes, we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). For continuous outcomes, we calculated the mean difference (MD) and its 95% CI. We assessed risk of bias in the included studies and created a summary of findings table using the GRADE approach. We included four studies in the review. The total number of participants was not identifiable, as some studies provided number of participants included, and some only patient days. The studies compared a package of structured assessment methods with a control group that included routine nursing care and drug therapy or unstructured psychiatric observations/treatment based on clinical judgement. In two studies, information about treatment in control care was not available. One study reported results for our primary outcome, clinically important change in aggressive/violent behaviour, measured by the rate of severe aggression events. There was likely a positive effect favouring structured risk assessment over standard professional care (RR 0.59, 95% CI 0.41 to 0.85; 1 RCT; 1852 participants; corrected for cluster design: RR 0.59, 95% CI 0.37 to 0.93; moderate-certainty evidence). One trial reported data for the use of coercive measures (seclusion room). Compared to standard professional care, structured risk assessment may have little or no effect on use of seclusion room as days (corrected for cluster design: RR 0.92, 95% CI 0.27 to 3.07; N = 20; low-certainty evidence) or use of seclusion room as secluded participants (RR 1.83, 95% CI 0.39 to 8.7; 1 RCT; N = 20; low-certainty evidence). However, seclusion room may be used less frequently in the standard professional care group compared to the structured risk assessment group (incidence) (corrected for cluster design: RR 1.63, 95% CI 0.49 to 5.47; 1 RCT; N = 20; substantial heterogeneity, Chi2 = 0.0; df = 0.0; P = 0.0; I2 = 100%; low-certainty evidence). There was no evidence of a clear effect on adverse events of escape (RR 0.2, 95% CI 0.01 to 4.11; 1 RCT; n = 200; very low-certainty evidence); fall down (RR 0.33, 95% CI 0.04 to 3.15; 1 RCT; n = 200; very low-certainty evidence); or choking (RR 0.2, 95% CI 0.01 to 4.11; 1 RCT; n = 200; very low-certainty evidence) when comparing structured risk assessment to standard professional care. There were no useable data for patient-related outcomes such as global state, acceptance of treatment, satisfaction with treatment, quality of life, service use, or costs. Based on the available evidence, it is not possible to conclude that structured aggression or violence risk assessment methods are effective for people with schizophrenia or schizophrenia-like illnesses. Future work should combine the use of interventions and structured risk assessment methods to prevent aggressive incidents in psychiatric inpatient settings.

Long-term impact of home-based monitoring after an admission for acute decompensated heart failure: a systematic review and meta-analysis of randomised controlled trials

Patients with heart failure have high rehospitalisation rates and poor cardiovascular outcomes. Home-based monitoring (HBM) has emerged with promising results in different settings. However, its long-term effects on patients recently admitted for acute decompensated heart failure (ADHF) remain uncertain. We systematically searched PubMed, Embase, and Cochrane Library for randomised controlled trials (RCTs) comparing HBM with usual care (UC) that were published between database inception and June 24, 2023. We included studies with patients admitted for ADHF in the previous 6 months and with a minimum follow-up of 6 months. We excluded studies with patients hospitalised for reasons other than ADHF and studies with disproportional education interventions between arms. Statistical analyses were performed using R software version 4.3.2. We pooled risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI) for categorical and continuous outcomes, respectively. Cochrane Collaboration's tool for assessing risk of bias in RCTs (RoB 2) was used to assess study quality. Publication bias was assessed via funnel plots and Egger's test, and heterogeneity was assessed through I2 statistics and sensitivity analysis. The protocol for this systematic review and meta-analysis was registered in the International Prospective Register of Systematic Reviews (PROSPERO, CRD42023465359). We included 16 RCTs comprising 4629 patients, of whom 2393 (51.7%) were randomised to HBM and 3150 (68%) were men. Follow-up ranged from six to fifteen months. As compared with UC, HBM significantly reduced all-cause mortality (RR 0.75; 95% CI 0.61, 0.91; p=0.005), all-cause hospitalisations (RR 0.82; 95% CI 0.70, 0.97; p=0.018), cardiovascular (CV) mortality (RR 0.53; 95% CI 0.36, 0.79; p=0.002), hospitalisations for heart failure (RR 0.75; 95% CI 0.62, 0.91; p=0.004), and CV hospitalisations (RR 0.72; 95% CI 0.55, 0.95; p=0.018). There were no significant differences in length of hospital stay (MD 0.97 days; 95% CI -0.90, 2.84; p=0.308). In patients recently admitted with ADHF, HBM significantly reduces long-term all-cause mortality and hospitalisations, CV mortality and hospitalisations, and hospitalisations for heart failure, as compared with UC. This supports the implementation of HBM as a standard practice to optimise patient outcomes following admissions for ADHF. However, future studies are warranted to evaluate the efficacy and safety of implementing HBM in the real-world setting. None.

Prenatal ochratoxin A exposure, birth outcomes and infant growth in rural Burkina Faso: a human biomonitoring sub-study from the MISAME-III trial

Mycotoxin exposure during pregnancy has been associated with adverse birth outcomes and poor infant growth in low- and middle-income countries. We assessed multiple biomarkers and metabolites of exposure to mycotoxins during pregnancy and their associations with birth outcomes and infant growth in 305 pregnant participants, between 30 and 34 completed weeks of gestation, in rural Burkina Faso. In this study, whole blood microsamples were analyzed for mycotoxin concentrations using ultra-performance liquid chromatography coupled to tandem mass spectrometry. Unadjusted and adjusted associations between mycotoxin exposure, and birth outcomes and infant growth at 6 months were estimated using linear regression models for continuous outcomes and linear probability models with robust variance estimation for binary outcomes. Infant growth trajectories from birth to 6 months were compared by exposure status using mixed-effects models with random intercept for the individual infant and random slope for the infant’s age. Ochratoxin A (OTA) exposure was detected in 50.8% of the study participants, with aflatoxin G1, aflatoxin M1, cyclopiazonic acid, deoxynivalenol and T-2-toxin being detected in the range of 0.33% and 2.31% of the population. We found no statistically significant ( p ≥ 0.05) associations between OTA exposure, and birth outcomes and infant growth. Despite this, the findings indicate a significant presence of ochratoxin A among pregnant participants. Public health policies and nutrition-sensitive interventions must ensure that OTA exposure is reduced in Burkina Faso.

Sample size and power calculation for testing treatment effect heterogeneity in cluster randomized crossover designs.

The cluster randomized crossover design has been proposed to improve efficiency over the traditional parallel-arm cluster randomized design. While statistical methods have been developed for designing cluster randomized crossover trials, they have exclusively focused on testing the overall average treatment effect, with little attention to differential treatment effects across subpopulations. Recently, interest has grown in understanding whether treatment effects may vary across pre-specified patient subpopulations, such as those defined by demographic or clinical characteristics. In this article, we consider the two-treatment two-period cluster randomized crossover design under either a cross-sectional or closed-cohort sampling scheme, where it is of interest to detect the heterogeneity of treatment effect via an interaction test. Assuming a patterned correlation structure for both the covariate and the outcome, we derive new sample size formulas for testing the heterogeneity of treatment effect with continuous outcomes based on linear mixed models. Our formulas also address unequal cluster sizes and therefore allow us to analytically assess the impact of unequal cluster sizes on the power of the interaction test in cluster randomized crossover designs. We conduct simulations to confirm the accuracy of the proposed methods, and illustrate their application in two real cluster randomized crossover trials.

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement In Patients With Aortic Stenosis: A Systematic Review and Meta-analysis

Aortic stenosis is a common and significant valve condition requiring bioprosthetic heart valves (BHV) with transcatheter aortic valve replacement (TAVR) being strongly recommended for high-risk patients or patients over 75. This meta-analysis aimed to pool existing data on post-procedural clinical as well as echocardiographic outcomes comparing ViV-TAVR to redo-SAVR to assess the short-term and medium-term outcomes for both treatment modalities. A systematic literature search on Cochrane Central, Scopus, and Medline (PubMed interface) electronic databases from inception to August 2023. We used odds ratios (OR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Twenty-four studies (25,216 patients) were pooled with a mean follow-up of 16.4 months. The analysis revealed that ViV-TAVR group showed a significant reduction in 30-day mortality (OR: 0.50 (95% CI: 0.43, 0.58), P < 0.00001), new-onset atrial fibrillation (OR: 0.34 (95% CI: 0.17, 0.67) P = 0.002), major bleeding event (OR: 0.28 (95% CI: 0.17, 0.45), P < 0.00001) and lower rate of device success (OR: 0.25 (95% CI: 0.12, 0.53), P = 0.0003). There were no significant differences between either group when assessing 1-year mortality, stroke, M.I, post-operative LVEF, and effective orifice area. ViV-TAVR cohort showed a significantly increased incidence of paravalvular leaks, aortic regurgitation, and increased mean aortic valve gradient. ViV-TAVR is a viable short-term option for elderly patients with high comorbidities and operative risks, reducing perioperative complications and improving 30-day mortality with no significant cardiovascular adverse events. However, both treatment modalities present similar results on short to medium-term complications assessment.

Effectiveness of trans-nasal humidified rapid insufflation ventilatory exchange compared with standard facemask oxygenation for pre- and apneic oxygenation during anesthesia induction: A meta-analysis based on randomized controlled trials.

To further identify the effectiveness of trans-nasal humidified rapid insufflation ventilatory exchange (THRIVE) for pre- and apneic oxygenation during the anesthesia induction by comparison to facemask ventilation (FMV) based on current available evidence. Medline, EMBASE, Web of Science, Cochrane Library and CNKI databases were searched from inception to December 22, 2023 for available randomized controlled trials (RCTs). Primary outcomes were PaO2 and PaCO2 after intubation and safe apnoea time. Secondary outcomes included the O2 desaturation, end expiratory carbon dioxide (EtCO2) and complications. The effect measures for continuous and categorical outcomes were separately the mean difference (MD) and relative risk (RR) with 95% confidence interval. Twelve RCTs with 403 patients in the THRIVE group and 401 patients in th FMV group were included. Pooled results demonstrated that the PaO2 after intubation was significantly higher (MD = 82.90mmHg, 95% CI: 12.25~153.54mmHg, P = 0.02) and safe apnoea time (MD = 103.81s, 95% CI: 42.07~165.56s, P = 0.001) was longer in the THRIVE group. Besides, the incidence rate of O2 desaturation (RR = 0.28, 95% CI: 0.12-0.66, P = 0.004) and gastric insufflation (RR = 0.26, 95% CI: 0.13-0.49, P<0.001) was significantly lower in the THRIVE group. Based on current evidence, THRIVE manifested better effectiveness representing as improved oxygenation, prolonged safe apnoea time and decreased risk of complications compared to standard FMV in surgical patients. Therefore, THRIVE could be served as a novel and valuable oxygenation technology for patients during anesthesia induction.

Breast Cancer Disease Prediction Using Random Forest Regression and Gradient Boosting Regression

The current research endeavors to evaluate the efficacy of regression-based machine learning algorithms through an assessment of their performance using diverse metrics. The focus of our study involves the implementation of the breast cancer Wisconsin (Diagnostic) dataset, employing both the random forest and gradient-boosting regression algorithms. In our comprehensive performance analysis, we utilized key metrics such as Mean Squared Error (MSE), R-squared, Mean Absolute Error (MAE), and Coefficient of Determination (COD), supplemented by additional metrics. The evaluation aimed to gauge the algorithms' accuracy and predictive capabilities. Notably, for continuous target variables, the gradient-boosting regression model emerged as particularly noteworthy in terms of performance when compared to other models. The gradient-boosting regression model exhibited remarkable results, highlighting its superiority in handling the breast cancer dataset. The model achieved an impressively low MSE value of 0.05, indicating minimal prediction errors. Furthermore, the R-squared value of 0.89 highlighted the model's ability to explain the variance in the data, affirming its robust predictive power. The Mean Absolute Error (MAE) of 0.14 reinforced the model's accuracy in predicting continuous outcomes. Beyond these core metrics, the study incorporated additional measures to provide a comprehensive understanding of the algorithms' performance. The findings underscore the potential of gradient-boosting regression in enhancing predictive accuracy for datasets with continuous target variables, particularly evident in the context of breast cancer diagnosis. This research contributes valuable insights to the ongoing exploration of machine learning algorithms, providing a basis for informed decision-making in medical and predictive analytics domains.

Saline, chlorhexidine, and povidone-iodine alone or in combination with iodine povacrylex are effective antiseptics in chickens (Gallus gallus domesticus).

To evaluate the topical antiseptic activity of saline, chlorhexidine (CHX), and povidone-iodine (PI) scrubs on the skin of chickens with or without the addition of DuraPrep (DP). 7 healthy adult Orpington hens (Gallus gallus domesticus). The right apterium corporale laterale was swabbed for standard aerobic bacterial culture and colony-forming unit (CFU) determination. The apterium was divided into 3 areas and treated with sterile saline, CHX, or PI. Samples were collected by swabbing each area before and after additional treatment with DP. CFU's were counted after 48 hours of incubation. Statistical analysis was performed using a linear mixed model with a continuous outcome. Compared to saline, CHX and PI treatment without DP decreased CFU count by 119 (95% CI, 55 to 183; P < .001) and 123 (95% CI, 58 to 187; P < .001), respectively. The application of DP after CHX and PI further decreased CFU counts by 6 (P = .01) and 9 (P = .01), respectively. DP after saline treatment decreased counts by 128 CFU (95% CI, 63 to 192; P < .001). No significant difference was detected between saline, PI, or CHX after DP application (-1.0 CFU; 95% CI, 63.4 to -65.4; P = .98 for both PI and CHX). CHX or PI provided greater reductions in bacterial CFU than saline, and all combinations with DP provided similar results. No notable cutaneous reactions were detected at any point. This data suggests that a scrub protocol including CHX or PI with DP is acceptable in surgical site preparation of chickens.

Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease.

Guidelines suggest that adults with diabetes and kidney disease receive treatment with angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). This is an update of a Cochrane review published in 2006. We compared the efficacy and safety of ACEi and ARB therapy (either as monotherapy or in combination) on cardiovascular and kidney outcomes in adults with diabetes and kidney disease. We searched the Cochrane Kidney and Transplants Register of Studies to 17 March 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. We included studies evaluating ACEi or ARB alone or in combination, compared to each other, placebo or no treatment in people with diabetes and kidney disease. Two authors independently assessed the risk of bias and extracted data. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. One hundred and nine studies (28,341 randomised participants) were eligible for inclusion. Overall, the risk of bias was high. Compared to placebo or no treatment, ACEi may make little or no difference to all-cause death (24 studies, 7413 participants: RR 0.91, 95% CI 0.73 to 1.15; I2 = 23%; low certainty) and with similar withdrawals from treatment (7 studies, 5306 participants: RR 1.03, 95% CI 0.90 to 1.19; I2 = 0%; low certainty). ACEi may prevent kidney failure (8 studies, 6643 participants: RR 0.61, 95% CI 0.39 to 0.94; I2 = 0%; low certainty). Compared to placebo or no treatment, ARB may make little or no difference to all-cause death (11 studies, 4260 participants: RR 0.99, 95% CI 0.85 to 1.16; I2 = 0%; low certainty). ARB have uncertain effects on withdrawal from treatment (3 studies, 721 participants: RR 0.85, 95% CI 0.58 to 1.26; I2 = 2%; low certainty) and cardiovascular death (6 studies, 878 participants: RR 3.36, 95% CI 0.93 to 12.07; low certainty). ARB may prevent kidney failure (3 studies, 3227 participants: RR 0.82, 95% CI 0.72 to 0.94; I2 = 0%; low certainty), doubling of serum creatinine (SCr) (4 studies, 3280 participants: RR 0.84, 95% CI 0.72 to 0.97; I2 = 32%; low certainty), and the progression from microalbuminuria to microalbuminuria (5 studies, 815 participants: RR 0.44, 95% CI 0.23 to 0.85; I2 = 74%; low certainty). Compared to ACEi, ARB had uncertain effects on all-cause death (15 studies, 1739 participants: RR 1.13, 95% CI 0.68 to 1.88; I2 = 0%; low certainty), withdrawal from treatment (6 studies, 612 participants: RR 0.91, 95% CI 0.65 to 1.28; I2 = 0%; low certainty), cardiovascular death (13 studies, 1606 participants: RR 1.15, 95% CI 0.45 to 2.98; I2 = 0%; low certainty), kidney failure (3 studies, 837 participants: RR 0.56, 95% CI 0.29 to 1.07; I2 = 0%; low certainty), and doubling of SCr (2 studies, 767 participants: RR 0.88, 95% CI 0.52 to 1.48; I2 = 0%; low certainty). Compared to ACEi plus ARB, ACEi alone has uncertain effects on all-cause death (6 studies, 1166 participants: RR 1.08, 95% CI 0.49 to 2.40; I2 = 20%; low certainty), withdrawal from treatment (2 studies, 172 participants: RR 0.78, 95% CI 0.33 to 1.86; I2 = 0%; low certainty), cardiovascular death (4 studies, 994 participants: RR 3.02, 95% CI 0.61 to 14.85; low certainty), kidney failure (3 studies, 880 participants: RR 1.36, 95% CI 0.79 to 2.32; I2 = 0%; low certainty), and doubling of SCr (2 studies, 813 participants: RR 1.14, 95% CI 0.70 to 1.85; I2 = 0%; low certainty). Compared to ACEi plus ARB, ARB alone has uncertain effects on all-cause death (7 studies, 2607 participants: RR 1.02, 95% CI 0.76 to 1.37; I2 = 0%; low certainty), withdrawn from treatment (3 studies, 1615 participants: RR 0.81, 95% CI 0.53 to 1.24; I2 = 0%; low certainty), cardiovascular death (4 studies, 992 participants: RR 3.03, 95% CI 0.62 to 14.93; low certainty), kidney failure (4 studies, 2321 participants: RR 1.15, 95% CI 0.67 to 1.95; I2 = 29%; low certainty), and doubling of SCr (3 studies, 2252 participants: RR 1.18, 95% CI 0.85 to 1.64; I2 = 0%; low certainty). Comparative effects of different ACEi or ARB and low-dose versus high-dose ARB were rarely evaluated. No study compared different doses of ACEi. Adverse events of ACEi and ARB were rarely reported. ACEi or ARB may make little or no difference to all-cause and cardiovascular death compared to placebo or no treatment in people with diabetes and kidney disease but may prevent kidney failure. ARB may prevent the doubling of SCr and the progression from microalbuminuria to macroalbuminuria compared with a placebo or no treatment. Despite the international guidelines suggesting not combining ACEi and ARB treatment, the effects of ACEi or ARB monotherapy compared to dual therapy have not been adequately assessed. The limited data availability and the low quality of the included studies prevented the assessment of the benefits and harms of ACEi or ARB in people with diabetes and kidney disease. Low and very low certainty evidence indicates that it is possible that further studies might provide different results.

Impact of atopic dermatitis lesion locations and extent on patient burden: A real‐world study

AbstractBackgroundAtopic dermatitis (AD) is associated with patient burden, but few studies describe the anatomic distribution of the disease or the impact of number of lesion locations.ObjectivesTo describe lesion locations and assess the relationship between the number of lesion locations (disease extent) and disease burden in patients with AD.MethodsThis cross‐sectional study included adults with dermatologist‐ or dermatology practitioner‐diagnosed AD enroled in the CorEvitas AD Registry (2020–2021) who initiated systemic therapy within 12 months prior to or at enrolment or had moderate‐to‐severe AD (vIGA‐AD® ≥3 and EASI ≥12) at enrolment. Thirteen areas of lesion involvement were assessed using a body map, and numbers of lesion locations were categorised as: 0, 1, 2–3, 4–6 and ≥7. Demographics, disease characteristics, PROs by number of lesion locations were descriptively compared using effect sizes (ES). The ES thresholds for small, medium, and large differences, respectively, were 0.10, 0.30, and 0.50 for phi (categorical outcomes) and 0.10, 0.25 and 0.40 for Cohen's f (continuous outcomes).ResultsAmong 1211 patients, lesion involvement was most frequent on the arms (69.5%) and lower limbs (61.7%). A total of 10.6%, 9.3%, 20.1%, 26.3% and 33.8% of patients had 0, 1, 2–3, 4–6 and ≥7 lesion locations, respectively. Current use of systemic (≥81.2%) and topical ( ≥74.7%) therapies was common, irrespective of lesion location. Disease severity increased with number of lesion locations: mean total BSA (ES = 1.17), EASI (ES = 1.11), and SCORAD (ES = 1.21). vIGA‐AD ≥3 was observed in 28.3%, 45.3%, 78.0%, and 93.9% of patients with 1, 2–3, 4–6 and ≥7 locations, respectively (ES = 0.63). Greater number of lesion locations was associated with worse PROs: mean POEM (ES = 0.57), sleep loss (ES = 0.41), peak pruritus (ES = 0.50), DLQI (ES = 0.40), and ADCT (ES = 0.53). Uncontrolled AD (ADCT ≥7) was observed in 48.2%, 52.9%, 70.4%, 81.6% of patients with 1, 2–3, 4–6 and ≥7 locations, respectively (ES = 0.42).ConclusionsAD lesions were reported for each body area assessed. Greater number of lesion locations was associated with increased disease severity, poor disease control, and decreased quality of life. Patients experienced substantial disease burden regardless of number of lesion locations involved.